Defibrillators, Implantable, Telemedicine
Conditions
Keywords
Tele medicine, ICD follow-up, Cost / benefit study
Brief summary
The implantable cardioverter defibrillator (ICD) has been shown to be effective in preventing mortality in patients with ventricular tachyarrhythmia. However, the expanding indications of this therapy will have an impact on the follow-up policy. Currently, regular follow-up visits are scheduled every 3 months. In this context, the recently-introduced remote monitoring devices constitute a promising new technique, allowing to transmit information about the status of the device and ICD therapies, without direct contact between patients and physicians. This monitoring by tele-follow-up might reduce the cost of care by avoiding useless visits to the implantation centre. The aim of our study is to assess the cost-benefit ratio of tele-follow-up assisted care as compared with the conventional ICD follow-up.
Detailed description
The implantable cardioverter defibrillator (ICD) has been shown to be effective in preventing mortality in patients with ventricular tachyarrhythmia. However, the expanding indications of this therapy will have an impact on the follow-up policy. Currently, regular follow-up visits are scheduled every 3 months. In this context, the recently-introduced remote monitoring devices constitute a promising new technique, allowing to transmit information about the status of the device and ICD therapies, without direct contact between patients and physicians. This monitoring by tele-follow-up might reduce the cost of care by avoiding useless visits to the implantation centre. The aim of our study is to assess the cost-benefit ratio of tele-follow-up assisted care as compared with the conventional ICD follow-up. Thanks to an open label, randomized, 2 arms study : one using a telephone follow up, the other a conventional follow-up.
Interventions
OTHERTele- follow-up
Remote transmission to the implantation centre every 3 months
Visits at the implantation centre every 3 months
Sponsors
Ministry of Health, France
Rennes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults over 18, * First implantation of an implantable cardioverter defibrillator device (CRT-D devices being excluded), single or dual-chamber in primary or secondary prevention, * ICD with data-transmission features, * GSM mobile phone network at patient home compatible with remote transmission, * Patient able to use correctly the transmission system, * Patients having given a written informed consent.
Exclusion criteria
* Class IV of NYHA, * Concomitant pathology leading to a life expectancy inferior to the protocol duration, * Concomitant participation to another protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of major cardiovascular events: all cause death, hospitalisation for a cardiovascular event, unsuccessful ICD therapies, and inappropriate ICD therapies. | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Death rate | 1 year |
| Hospitalisation rate for a cardiovascular event | 1 year |
| Rate of unsuccessful or inappropriate ICD therapies | 1 year |
| Mean costs of each follow-up strategy | 1 year |
| Number of non programmed additional consultations at the implantation centre | 1 year |
| Time to onset of the first major cardiovascular event (censored criterion) | 1 year |
| Number of drop-outs in the tele-follow-up group | 1 year |
| Adherence of the patients to the tele-follow-up strategy | 1 year |
| Feasibility of the tele-follow-up in implantation centres | 1 year |
| Cost-benefit analysis | 1 year |
| Number and cause of device re-programming | 1 year |
Countries
France
Outcome results
None listed